The present invention relates generally to connectors and more specifically relates to connectors for use in introducing medication into a patient and for removing fluids from the patient.
Modern medical practice commonly employs intravenous (I.V.) solutions to administer medications to patients. In most such applications, an intravenous solution flows from an elevated container through tubing which is connected to a needle inserted directly into the patient's vein. Intermittent or "piggy-back" medications are typically added to the intravenous solution at a connector placed in the tubing known as a "Y-site" connector. Y-site connectors generally include a sealed entry port which is integral to the tubing through which fluid flows to (or from) the patient. The sealed entry port of a Y-site connector is typically constructed from a latex plug (generally known as a septum). Medication is introduced into the tubing by penetrating the septum with a secondary needle connected to a syringe or other source of medication. The latex septum is advantageous in that it allows for multiple needle insertions to access a patient's system with no pain or discomfort to the patient. The latex septum is self-healing, and upon removal of the needle the hole through the septum closes thus maintaining a closed system. The self-healing feature of the latex septum as well as its flat surface serve as distinct advantages inasmuch as before and after each needle insertion, the exterior surface of the septum can be easily wiped down with alcohol to disinfect the surface and minimize the introduction of bacteria and infection to the patient.
One major drawback with the above-referenced conventional practice is that, in addition to the primary needle used to puncture the patient's vein, it necessitates the use of a secondary needle to puncture the septum. Once this secondary needle is exposed to a patient's body fluids it is considered high risk and threatens the health of healthcare workers. Used needles must be handled and disposed of very carefully and the mishandling of used needles accounts for a large percentage of life-threatening injuries to medical personnel.
Several devices have been developed for providing secondary access to a patient's bloodstream without the use of a needle. For example, U.S. Pat. No. 3,570,484 issued to Steer, et al. discloses a device for administering intravenous injections of liquid. U.S. Pat. No. 4,324,239 issued to Gordon, et al. relates to a safety valve for catheterization and is characterized by a piston having an internal flow path. A portion of the piston is surrounded by an elastomeric member which biases the piston in a closed position. Although the above-referenced devices do eliminate the secondary needle connection, and therefore eliminate the risk of needle stick injury to medical personnel, they both present designs which present an unnecessary risk of infection to the patient. This risk is primarily due to the devices are designed with external crevices which promote the pooling of fluid on and around the external surfaces of the device. This pooling effect creates a fluid reservoir during the normal course of using the device. Ideally, a device connected to a patient's bloodstream should not promote pooling during the normal course of its use due to the potential for bacterial infection. If the fluid reservoir or cavity is not clean, bacteria may develop in the reservoir. That bacteria could find its way into a patient's bloodstream when the device is used to administer new medication or to remove fluids from the patient's bloodstream.
While, as discussed above, in most applications it is desirable to eliminate the needle in secondary connections, it is generally accepted that in some applications the use of a needle to make the secondary connection is expedient. For example, certain medications are commonly prepackaged in needle assemblies. When using prepackaged medications, it is understood that it is desirable to simply insert the needle through the latex septum of the Y-site connector and dispose the medication into the I.V. solution.
It is desirable that such a needleless connector be inexpensive to manufacture, disposable, and easily adaptable for use in various medical applications.
Thus it is an object of this invention to eliminate the necessity of using a secondary needle as a component in tubing connections related to intravenous delivery of medication while still providing for the use of a needle in circumstances where expedient, such as in the case of medication which is prepackaged in needle assemblies.
It is a further object of this invention to provide a Y-site connector which is easily connectable to a syringe, I.V. administration sets, or other standard medical fittings.
It is still a further object of this invention to provide a Y-site connector which is extremely simple in design, inexpensive to produce, and easy to disinfect.